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Antibacterial Agent
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
Phase < 1
Waitlist Available
Research Sponsored by CDA Research Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group
Summary
LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..
Eligible Conditions
- BV
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Presence or absence of bacterial vaginosis at the end of the study
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LUXSOL CreamExperimental Treatment1 Intervention
LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.
Group II: Metronidazole creamActive Control1 Intervention
Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert.
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Who is running the clinical trial?
CDA Research Group, Inc.Lead Sponsor
4 Previous Clinical Trials
236 Total Patients Enrolled